Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing dried Aurantiochytrium Administration: Take one capsule with water once daily *If you forget to take the test food, take it as soon as you remembe
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects whose systolic blood pressure is between 130 mmHg and 139 mmHg
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who usually take health foods containing ingredients which may influence blood pressure 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are a smoker 9. Subjects whose daily alcohol intake exceeds 20 g 10. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 11. Subjects who suffer from COVID-19 12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 13. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of systolic blood pressure at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of changes in systolic blood pressure between screening (before consumption; Scr) and 12w 2. The measured values of diastolic blood pressure, flow-mediated dilation (FMD), maximum expansion width of the blood vessel, and the resting vessel diameter at 12w, and the amount of changes from Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed